Implant methods and devices for influencing body fluids

ABSTRACT

An implant method according to which an implant which comes in contact with a body fluid is placed in communication with a reservoir having a relatively large supply of an agent for influencing a component of the body fluid. The device has a tubular portion which receives the body fluid and which communicates with a reservoir which contains the agent for influencing the component of the body fluid.

United States Patent Bucalo Dec. 10, 1974 IMPLANT METHODS AND DEVICESFOR 3,416,530 12/1968 Ness 128/260 INFLUENCING BODY FLUIDS M41561 5/19693,505,991 4/1970 Hellersteln et al l28/1.1 Inventor: Louis Bucalo,Holbrook, NY 3,704,704 12/1972 Gonzales 128/1 R Assigneez Invesmrs Inventures, Inc, New 3,742,933 7/1973 Bucalo 128/1R York, NY. PrimaryExaminer-Dalton L. Truluck 22 F1 d: l 2 l 7 1 1e Juy 9 3 Attorney,Agent, or Firm-Steinberg & Blake 21 Appl. No.: 375,359

I Related US. Application Data [63] Continuation-in-part of Ser. No.155,141, June 21, [57] ABSTRACT 1971 An implant method according towhich an implant which comes in contact with a body fluid is placed in128/ communication with a reservoir having a relatively I large supplyof an agent for influencing a component [58] w of Search 128/1 303 2/ ofthe body fluid. The device has a tubular portion which receives the bodyfluid and which communi- 56 R f Ct d cates with a reservoir whichcontains the agent for in- 1 UNITED 11 3; ILZTENTS fluencing thecomponent of the body fluid.

3,053,255 9/1962 Meyer 128/268 16 Claims, 6 Drawing Figures Pmmw w3853L116 F764 7 is i 64 66 Iii 22 a 7 54 IMPLANT METHODS AND DEVICES FORINFLUENCING BODY FLUIDS CROSS REFERENCE TO RELATED APPLICATION Thisapplication is a continuation-in-part of copending application Ser. No.155,141, filed June 21, 1971 and entitled DEVICE FOR CONTROLLING FLUIDFLOW IN LIVING CREATURES, now US. Pat. No.

3,742,933, which issued July 3, 1973.

BACKGROUND OF THE INVENTION The present invention relates to implantmethods and devices for influencing body fluids in living beings.

It has been proposed to include in methods and devices of this type anagent for influencing at least a component of the body fluid. However,with methods and devices of this nature there is a problem ofmaintaining a sufficient supply of the agent in the body for assuringthe desired influence over a long period of time.

A further problem encountered with methods and devices of the above typeis in connection with achieving a desired precise control of theinfluence on the component of the body fluid. Thus, while it has beenproposed to provide arrangements according to which it is possible toplace a body fluid either in communication with an agent which willinfluence a component thereof or completely out of communication withsuch an agent, it has not been possible heretofore to control the extentof the influence of the agent on the component of the body fluid.

SUMMARY OF THE INVENTION It is accordingly a primary object of thepresent in vention to provide methods and devices which will solve theabove problems.

Thus, it is one of the important objects of the present invention toprovide a method and device which will enable a body fluid to bemaintained in contact with an agent for influencing a component of thebody fluid over as long a period as might practically be desired in anygiven living being such as a human being, with the assurance that theinfluence of the agent on the component of the body fluid will bemaintained effective throughout the long period which may be throughoutthe life of a given living being such as a human being.

It is also an object of the present invention to provide a method anddevice of the above type which is capable of controlling the extent towhich a component of a body fluid is influenced by an agent, so that inthis. way excessive control from an agent can be reduced and instead aprecise selection of the extent of influence of a given agent on acomponent of the body fluid can be achieved.

A more specific object of the present invention is to solve the aboveproblems in connection with semen of a human male by influencing thesperm suspended in the semen.

Thus, in accordance with the present invention an implant is situated ina body cavity to come in contact with a body fluid, and the implant isplaced in communication with a reservoir having a supply of an agent forinfluencing at least a component of the body fluid, this supply of theagent being sufficiently large to assure the desired influence from theagent over as long a period as desired.

Also, according to the invention the device includes a tubular meanshaving a hollow interior for receiving ceived in the interior of thetubular means. The reservoir means is capable of containing a supply ofthis agent which is great enough to assure the effective influencethereof on the component of the body fluid for as long as may bedesired.

BRIEF DESCRIPTION OF DRAWINGS The invention is illustrated by way ofexample in the accompanying drawings which form part of this applicationand in which:

FIG. 1 is a schematic longitudinal sectional elevation of one embodimentof a device and method of the present invention;

FIG. 2 is a sectional plan view of the device of FIG. 1 showing insection the housing of the illustrated valve and the reservoir meanwhich communicates with the movable valve member;

FIG. 3 is a sectional elevation similar to FIG. 1' but showing only thevalve housing section;

FIG. 4 is a schematic sectional elevation of another embodiment of adevice and method according to the invention;

FIG. 5 is a schematic sectional elevation of a still further embodimentof a device and method according to the present invention; and

FIG. 6 is a schematic illustration of a further embodiment of amethodaccording to the invention.

DESCRIPTION OF PREFERRED EMBODIMENTS Referring first to FIG. 1, there isillustrated therein an implant 10 according to the present invention.This implant 10 is shown as including a valve housing 12 having a pairof elongated tubular portions 14 which form, respectively, an inlet andoutlet for the valve. The valve housing 12 has an upwardlyextending\tubular portion 16, as viewed in FIG. 1, and this portionreceives a rotary stem 18 capable of being turned in any suitable way asby the handle portion 20. The stem 18 is connected with a rotary valvemember 22 seated fluidtightly in the housing 12 and formed with apassage 24 of substantially V-shaped configuration which forms a tubularmeans for receiving a body fluid.

In the illustrated example the elongated rotary stem 18 is itself hollowand forms a reservoir means for containing an agent 26 for influencingat least a component of the body fluid. This agent 26 in the example ofFIG. I is a solid in the form of an elongated rod which is retained inthe hollow interior of the reservoir means 18 by any suitable means suchas the threaded plug 28. It will be noted that the rod 26 extends withclearance through the hollow interior of the reservoir means 18 from thelatter into the tubular means 24 so that the body fluid received in thetubular means 24 will also be received in the interior of the reservoirmeans 18 to come into engagement with a relatively largearea of theagent 26.

The rotary valve member 22 is'formed with a second passage 30 extendingtransversely through the rotary valve member 22 in a directionperpendicular to that of the passage 24. Thus, when it is desired toterminatethe influence of the agent 26 on the body fluid, the rotaryvalve member is turned by way of the element 20 to place the passage 30in communication with the inlet and outlet portions 14 and to terminatecommunication of the passage 24 with the inlet and outlet portions 14.

However, according to a present feature of the invention the passage 24communicates at its opposed ends with a pair of relatively short grooves32 which respectively extend in opposite directions from the ends of thepassage 24 along the exterior surface of the rotary valve member 22 inthe manner most clearly apparent from FIGS. 2 and 3. In the same way theopposed ends of the passage 30 respectively communicate with a pair ofrelatively short grooves 34 which respectively extend in oppositedirections from the opposed ends of the passage 30 along the exteriorsurface of the rotary valve member 22 in the manner shown most clearlyin FIGS. 2 and 3. Thus, it will be noted that the relatively shortgrooves 32 and 34 extend toward each other at the lower right and upperleft portions of FIG. 2. The passages 32 and 34 are situated in a planewhich contains the axis of the tubular portions 14 and which isperpendicular to the axis of the reservoir means 18. The angulardistance through which all of the grooves 32 and 34 extend are the same,this angular distance being somewhat less than 45.

As a result of this feature when the part 20 is manipulated to adjustthe angular position of the rotary valve member 22, it becomes posiblenot only to place either the passage 24 alone or the passage 30 alone incommunication with the tubular inlets and outlets 14, but in addition itis possible to situate the pairs of adjoining grooves 32 and 34simultaneously in communication with the tubular inlet and outletportions 14 with the angular position of the rotary valve member 22controlling the extent to which passages 22 and 24 communicate with thetubular inlet and outlet portions 14. In this way it becomes possible tocontrol the extent to which the component of the body fluid isinfluenced by i the agent 26.

One of the specific uses for an implant method and device as describedabove in connection with FIGS. 1-3 is in the case of a human male wherethe implant may be situated in a body cavity formed by a vas deferensand where the agent 26 is a spermicidal agent. For example, in the casewhere the agent is a solid in the form of a rod as shown in FIGS. 1-3,this agent 26 may take the form of a copper rod or a rod made of anysolid material which will have a spermicidal capability, such as a rodof an alloy of copper with materials such as zinc and nickel. Thus,these latter metals are also known to be spermicidal agents, and ofcourse in addition it is known that tin, silver, and magnesium havespermicidal properties. Also, certain plastics such as celluloid may beused as the spermicidal agent.

The principle according to which the influence of the agent on acomponent of a body fluid is controlled is illustrated according to afurther method of the invention in FIG. 6. Thus, referring to FIG 6,there are schematically illustrated therein the testes 36, eachadjoining an epididymis 40, with the latter respectively communicatingwith the extensions forming the pair of vas deferentia 42. The vasdeferentia 42 in turn respectively communicate with the schematicallyillustrated seminal vesicles 44 beyond which is located the ejaculatoryduct or urethra 46 in which the fluids of the vas deferentia 42 join.

In accordance with the method of the invention which is illustrated inFIG. 6, an implant such as a valve 48 is situated only in one of thepair of vas deferentia 42. A number of advantages flow from thisparticular method of the invention. For example, in the case of animplant similar to that of FIGS. l-3 where a spermicidal agent is placedby the implant 48 in communication with the semen in only one of the vasdeferentia, the influence of the spermicidal agent may be strong enoughto prevent conception even though the semen flows in a completelyunobstructed fully natural manner through the left vas deferens 42 ofFIG. 6. In other words the spermicidal effect of the agent may be sostrong that when the fluids from the pair of vas deterentia 42 join eachother in the duct 46, the spermicidal effect is sufficiently great onthe fluid received from the left vas deferens 42 of FIG. .6 'to preventthe number of viable sperm in the ejaculated semen from resulting inconception. Therefore, when the implant 48 is adjusted so as toterminate the effect of the spermicidal agent, even if there should beany problems in reestablishing the flow of semen through the right vasdeferens 42 of FIG. 6, there would be no problem with respect to theleft vas deferens 42 of FIG. 6, so that the sperm in the semen flowingthrough the left vas deferens 42 of FIG. 6 would be fully viable whenthe influence of the spermicidal agent is terminated and thusreestablishment of the capability of conception by the male would beassured to an even greater degree with the method as illustrated in FIG.6.

Furthermore, an implant such as the implant 48 may take other forms. Forexample, instead of having a spermicidal agent, it may be used simply toterminate the flow ofsemen through the right vas deferens of FIG. 2while leaving the flow of semen through the left vas deferens of FIG 6unaffected. Such an arrangement is of particular utility in a case whereit is suspected by a physician that a patient having faulty sperm hasthe source of the faulty sperm from only one of the testes 36, so thatby terminating the flow in only one of the vas deferentia it becomespossible to effect a suitable cure. In addition, it is to be noted thatit may be suspected that sperm having one type of characteristic isderived from one of the vas deferentia, while sperm having anothercharacteristic is derived from the other of the vas deferentia, so thatwith a method as shown in FIG. 6 it becomes possible to prevent spermhaving particular characteristics from reaching the duct 46. Controls ofthis nature also may be provided with an arrangement as shown in FIG. 6.

It is to be noted that the specific details of the invention are notlimited to arrangements as shown in FIGS. l-3 and described above. Thus,FIG. 4 shows an implant 50 in the form of a valve also having tubularinlet and outlet portions 52, similar to the portions 14. However, inthis case'the valve housing has an elongated tu bular portion 54perpendicular to the portions 52 and supporting for sliding movement aspool valve member 56 having a pair of valve passages 58 and 60. In theposition shown in FIG. 4 the passage 58 is in communication with theinlet and outlet portions 52. However, by displacing the spool 56 untilit engages the flange 62,

the passage 60 will be placed in communication with the tubular inletand outlet portions 52. The housing portion 54 threadedly carries a ring64 which determines the position of position of the spool valve 56 shownin FIG. 4, and this spool valve may be maintained in any desiredposition by frictional engagement with the housing and it may be movedto the desired position by way of the adjusting rod 66.

As may be seen from FIG. 4, the spool valve 56 is formed with anelongated tubular portion 68 housing a rod 70 which may be thesame asthe rod 26 and which is held in the position shown in FIG, 4 by anysuitable means such as a threaded plug 72. Thus, when the passage 60 isplaced in communication with. the tubular portions 52, the effect of theagent 70 on the component of the body fluid will be provided, and inthis case also it is clear that the axially bored part of the spoolvalve 56 forms a reservoir means which contains the agent 70 whichcommunicates with the tubular means 60 which forms a passage for thebody fluid.

It is to be noted that in this case also the spool part 74 situatedbetween the tubular passages 58 and 60 is formed with a pair of axialgrooves 76 and 78 which respectively communicate with the passages 60and 58, so that the valve member 56 also may have either positions whereonly the tubular passage 58 or the tubular passage 60 communicates withthe tubular inlet and outlet portions 52 or where both of the passages58 and 60 simultaneously communicate with the tubular inlets and outletsso that in the same way as with the embodiment of FIGS. 1-3 it ispossible to regulate the extent of the influence of the agent 70 on thecomponent of the body fluid.

Furthermore, the use of a solid spermicidal agent is not essential.Thus, FIG. 5 shows an embodiment of the invention similar to that ofFIGS. 1-3 except that in this case a tubular means 80 of the rotaryvalve member extends downwardly beneath the transverse passage 82 of therotary valve member 84, this passage 82 of course corresponding in allrespects to the passage 30. Thus, the pair of inlet and outlet portions86 are capable of being in communication either with the passage 80 orthe passage 82 by turning the rotary valve member 84 in the mannerdescribed above.

With the embodiment of FIG. 5, the device includes a reservoir means 88in the form of a container which may contain a liquid agent 90 in theillustrated example. A wick 92 of the reservoir means extends into theliquid 90 and extends through a suitable opening in the valve housinginto the passage 80 as illustrated in FIG. 5, so that through this wick92 of the reservoir means the agent is supplied to the interior of thetubular means 80. Thus, in this way contact between the body fluid inthe passage 80 and the agent 90 is assured, and it becomes possible touse liquid agents with a method and device as shown in FIG. 5.

Of course, the agent, which may be a spermicidal agent in the specificcase of a vas valve, need not be completely liquid in the case of FIG. 5but can have a non-solid condition such as, for example, a semisolidpaste or jelly.

Nature and Properties of Chemical Contraceptives Type Example ActionHeavy Metals Hg SH inhibitor Surfactants Nonionic and anionic Membranedetergents; Cationic solubilizers detergents; Vitamin A-OH AntibioticsBacitracin Energy Spiromycin metabolism blockers; Filipin Membranedisrupters Antimycin Cations CA Interference with K motile mechanisms Znof sperm Enzyme inhibitors Inhibition of (Anti-acrosome enzymes)hyaluronidase and/or neuraminidase (DF) Antibodies Antibodies topurified Agglutinators sperm specific antigens or to acrosomal proteinsSeminal plasma Seminal spermine plusldiamine oxidase gives rise tounknown oxidation products (probably aldehydes) Name Ingredients Type I.Ortho-Gynol Jelly riconoleic acid, p-diisobutyl detergentphenoxypolyethanol, boric acid 2, Lanccn-jelly ricinoleic acid, surface(Esta prods.) hcxylresorcinol, active chlorothymol, glycerin, sodiumbenzoate 3, Trimo san Therapeuphenylmercuric acetate, heavy metal ticjelly (used as sodium lauryl sulfate detergent antifungus agent)Continued Jellies Name Ingredients Type 4 Lurophyn supposiphenylmercuricacetate, heavy metal tories and jelly polyethylene glycol nonionicsurfactant 5. Preceptin gel ricinoleic acid, surface (Ortho) pdiisobutylphenoxypolyactive ethoxy ethanol nonionic surfactant 6. Central Pastephenylmercuric heavy metal (Jelly, Egypt) nitrate inhibitor 7. O.A.K.Jelly hexyl resorcinol,

(Denmark) propylene glycol, sodium alginate 8. Dupree Jellyphenylmercury'borate, heavy metal oxyquinoline sulfate, redox lactate,borate inhibitor acid 9. Genoson Jelly ricinoleate, (surfactant)oxyquinoline sulfate, redox poison merthiolate l0. Kemi Jelly lactate,borate acid oxyquinoline sulfate redox block 1 l. M. Lex Crescent sodiumlauryl sulfonate anionic Jelly surfactant l2. Milex Crescent ricinoleicacid, glycerol, surface Jelly oxyquinoline sulfate active redoxinhibitor 13. Natogel Jelly oxyquinoline sulfate redox inhibitor 14.Safetycin Jelly phenylmercuric acetate heavy metal (Taiwan) (SHinhibitor) Creams l. Ortho-creme ricinoleic acid, sodium anionic laurylsulfate, boric detergent acid, nonoxynol 9 nonionic detergent 2. Creemoxcreme nonylphenoxy polyoxyethylene, nonionic beta napthol, phenoldetergent trioxymethylene acid 3. Kemi-creme paraformaldehyde oxidizingoleate agent protein inactivator surfactant 4. Tut'us Cremep-hydroxybenzoate (East Germany) aluminum subacetate heavy metalLetio-Lanette Wax Foams Name Ingredients Type Delphen Vaginalnonoxynol-9 nonion c Foam (oil-H O emulsion) surfactant What is claimedis: 1. In a method for controlling body fluid in a body cavity of aliving being, the steps of situating in the 45 body cavity of the livingbeing an implant which receives the body fluid which is to be controlledand which has in its interior an agent which is contacted by the bodyfluid and which influences at least a component of the body fluid, andplacing in communication 50 with the implant a reservoir containing arelatively large supply of said agent for replenishing the latter, sothat the influence of the agent on the component of the body fluid canbe maintained effective over a long period of time.

2. In a method as recited in claim 1 and wherein the agent is a solid.

3. In a method as recited in claim 2 and wherein the agent is a metal.

4. In a method as recited in claim 1 and wherein the agent is anon-solid.

5. In a method as recited in claim 4 and wherein the agent is a liquid.

6. In a method as recited in claim 1 and wherein the body cavity is avas deferens and the agent is a spermicidal agent.

7. In a method as recited in claim 1 and including the step of adjustingthe extent to which the component of the body fluid is exposed to theagent.

8. In a method for controlling semen in a male being having a pair ofvas deferentia, the step of connecting an implant with only one of thevas deferentia.

9. In a method as recited in claim 8 and wherein the implant is a valve.

10. An implant comprising tubular means having a hollow interior forreceiving a body fluid, an agent in said hollow interior of said tubularmeans for influencing at least a component of the body fluid, andreservoir means operatively connected with said tubular means andcommunicating with the hollow interior thereof, said reservoir meanscontaining said agent for replenishing the latter in the hollow interiorof said tubular means.

11. The combination of claim 10 and wherein said reservoir means formsan extension of the hollow interior of said tubular means and said agentis in the form of a solid body situated in said extension and saidtubular means.

12. The combination of claim 10 and wherein said agent is a liquid, saidreservoir means including a container which contains said liquid and awick extending from the interior of said container to the interior ofsaid tubular means and extending into the liquid.

13. The combination of claim 10 and wherein a valve means includes ahousing having an inlet and an outlet and also includes a movable valvemember situated between said inlet and outlet and formed with a passagewhich forms said tubular means, said valve member having at least oneposition where said passage communicates with said inlet and outlet sothat in the latter position of said valve member the agent in saidreservoir means is effective to influence the component of a body fluidwhich is received in the valve means.

14. The combination of claim 13 and wherein said valve member is formedwith a second passage which does not communicate with said reservoirmeans and which can selectively be placed in communication with theinlet and outlet to eliminate the influence of the agent.

15. The combination of claim 14 and wherein both of said passages haveconfigurations for mutually excluens and the agent is a spermicidalagent.

1. In a method for controlling body fluid in a body cavity of a livingbeing, the steps of situating in the body cavity of the living being animplant which receives the body fluid which is to be controlled andwhich has in its interior an agent which is contacted by the body fluidand which influences at least a component of the body fluid, and placingin communication with the implant a reservoir containing a relativelylarge supply of said agent for replenishing the latter, so that theinfluence of the agent on the component of the body fluid can bemaintained effective over a long period of time.
 2. In a method asrecited in claim 1 and wherein the agent is a solid.
 3. In a method asrecited in claim 2 and wherein the agent is a metal.
 4. In a method asrecited in claim 1 and wherein the agent is a non-solid.
 5. In a methodas recited in claim 4 and wherein the agent is a liquid.
 6. In a methodas recited in claim 1 and wherein the body cavity is a vas deferens andthe agent is a spermicidal agent.
 7. In a method as recited in claim 1and including the step of adjusting the extent to which the component ofthe body fluid is exposed to the agent.
 8. In a method for controllingsemen in a male being having a pair of vas deferentia, the step ofconnecting an implant with only one of the vas deferentia.
 9. In amethod as recited in claim 8 and wherein the implant is a valve.
 10. Animplant comprising tubular means having a hollow interior for receivinga body fluid, an agent in said hollow interior of said tubular means forinfluencing at least a component of the body fluid, and reservoir meansoperatively connected with said tubular means and communicating with thehollow interior thereof, said reservoir means containing said agent forreplenishing the latter in the hollow interior of said tubular means.11. The combination of claim 10 and wherein said reservoir means formsan extension of the hollow interior of said tubular means and said agentis in the form of a solid body situated in said extension and saidtubular means.
 12. The combination of claim 10 and wherein said agent isa liquid, said reservoir means including a container whic contains saidliquid and a wick extending from the interior of said container to theinterior of said tubular means and extending into the liquid.
 13. Thecombination of claim 10 and wherein a valve means includes a housinghaving an inlet and an outlet and also includes a movable valve membersituated between said inlet and outlet and formed with a passage whichforms said tubular means, said valve member having at least one positionwhere said passage communicates with said inlet and outlet so that inthe latter position of said valve member the agent in said reservoirmeans is effective to influence the component of a body fluid which isreceived in the valve means.
 14. The combination of claim 13 and whereinsaid valve member is formed with a second Passage which does notcommunicate with said reservoir means and which can selectively beplaced in communication with the inlet and outlet to eliminate theinfluence of the agent.
 15. The combination of claim 14 and wherein bothof said passages have configurations for mutually exclusive orsimultaneous communication with said inlet and outlet, and said valvemember being adjustable for providing only communication with one or theother of the passages or for providing a selected extent ofcommunication of the inlet and outlet with both of said passages forcontrolling the influence of the agent on the component of the bodyfluid.
 16. The combination of claim 15 and wherein the valve housing isadapted to be received in a vas deferens and the agent is a spermicidalagent.